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Trial registered on ANZCTR


Registration number
ACTRN12621000881831
Ethics application status
Approved
Date submitted
19/03/2021
Date registered
8/07/2021
Date last updated
1/10/2023
Date data sharing statement initially provided
8/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Scientific title
A Phase I Study of PTM-101 as Neoadjuvant Therapy for Borderline Resectable or Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Secondary ID [1] 303619 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic ductal adenocarcinoma (PDAC) 320998 0
Condition category
Condition code
Cancer 318804 318804 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PTM-101 is a biodegradable device containing 100mg of paclitaxel. PTM-101 will be placed onto the pancreatic surface overlying the tumor by a surgical oncologist trained in use of PTM-101 using standard laparoscopic surgical equipment as part of a standard of care staging laparoscopy. It is anticipated that placement of PTM-101 will add approximately 20 minutes to the time of the procedure (approximately 30 minutes typically), which will be conducted under general anaesthesia. Documentation of PTM-101 placement as part of the diagnostic laparoscopy will be collected. Once in place, PTM-101 will degrade over approximately 10 weeks.
Intervention code [1] 319910 0
Treatment: Devices
Intervention code [2] 320364 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326749 0
Acute PTM-101 deployment success rate as measured by applier during surgery
Timepoint [1] 326749 0
At time of placement procedure
Primary outcome [2] 326750 0
Safety/toxicity: composite rate of serious adverse events related to the PTM-101 film deployment procedure or PTM-101 film assessed via operative procedural case report forms, medical records review and at each follow-up visit
Timepoint [2] 326750 0
within 3 months of the study procedure, to be assessed weekly for 28 days and at 3 month follow-up
Primary outcome [3] 327281 0
Long-term PTM-101 deployment success rate as defined as PTM-101 visible in peri-tumoral area by imaging or at resection, whichever event occurs first.
Timepoint [3] 327281 0
At follow-up imaging, endoscopy or at resection (21-90 days post-procedure)
Secondary outcome [1] 392567 0
Paclitaxel levels in blood
Timepoint [1] 392567 0
Weekly within 28 days of the study procedure

Eligibility
Key inclusion criteria
1. EUS accessible, biopsy proven PDAC with borderline resectable or locally advanced disease by imaging criteria in accordance with International Consensus Guidelines (S Isaji, 2018)
2. No radiographic evidence of metastatic disease
3. No prior therapy for PDAC
4. ECOG 0 or 1
5. Clinically determined to be able to tolerate neoadjuvant therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any other active malignancy
2. Known HIV or active viral hepatitis
3. Active ongoing infection or autoimmune disease which would preclude administration of chemotherapy or surgical intervention
4. Inability to comply with activities and therapeutic interventions as outlined
5. Currently enrolled in another investigational drug or device trial
6. Women who are pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2021
Actual
23/09/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
20/12/2021
Date of last data collection
Anticipated
30/09/2022
Actual
29/12/2022
Sample size
Target
6
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307996 0
Commercial sector/Industry
Name [1] 307996 0
PanTher Therapeutics
Country [1] 307996 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
PanTher Therapeutics
Address
700 Main St.
Cambridge, MA 02139
Country
United States of America
Secondary sponsor category [1] 308718 0
Commercial sector/Industry
Name [1] 308718 0
Avania Clinical
Address [1] 308718 0
13/76 Reserve Rd, Artarmon, NSW, 2064
Country [1] 308718 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307990 0
The Alfred Health HREC
Ethics committee address [1] 307990 0
55 Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 307990 0
Australia
Date submitted for ethics approval [1] 307990 0
22/03/2021
Approval date [1] 307990 0
16/06/2021
Ethics approval number [1] 307990 0

Summary
Brief summary
This study will be investigating the safety and tolerability of an implantable device to administer chemotherapy directly to the tumour site for people with confirmed borderline resectable or locally advanced pancreatic cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have biopsy proven pancreatic ductal adenocarcinoma with borderline resectable or locally advanced disease that has not spread to other organs, and you have not had any prior treatment for your cancer.

Up to 12 participants who meet the inclusion criteria will be recruited for this study. All participants will undergo a standard diagnostic surgery at which time the trained surgeon will insert the intervention device directly onto the pancreas. The device will then slowly release a chemotherapy drug (paclitaxel) before being biodegraded. There is no need for a second surgery to remove the device. After the device has been inserted, all participants will undergo standard IV chemotherapy as prescribed by a doctor. Participants will be asked to provide weekly blood samples during the first 28 days and will undergo standard of care imaging (CT) to assess for device placement and response to therapy. Participants will be followed weekly for 1 month, at 3 months (for primary endpoints).

It is hoped that this research will determine whether an implantable biodegradable device intended to deliver chemotherapy directly to the pancreas is safe and tolerable in patients with pancreatic cancer. If the device is deemed to be safe, this may provide a new method of treatment for future pancreatic cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109150 0
Dr Charles Pilgrim
Address 109150 0
The Alfred
55 Commercial Rd
Melbourne, VIC 3000
Country 109150 0
Australia
Phone 109150 0
+61 3 9509 4811
Fax 109150 0
Email 109150 0
[email protected]
Contact person for public queries
Name 109151 0
Chris Brookes
Address 109151 0
The Alfred
55 Commercial Rd
Melbourne, VIC 3000
Country 109151 0
Australia
Phone 109151 0
+61 3 9076 2000
Fax 109151 0
Email 109151 0
[email protected]
Contact person for scientific queries
Name 109152 0
Laura Indolfi
Address 109152 0
PanTher Therapeutics, Inc. 191 Dexter Ave, Watertown, MA 02472
Country 109152 0
United States of America
Phone 109152 0
+1 857 413 1698
Fax 109152 0
Email 109152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.